FDA Adverse Event
Other
Summary report: N
FOUNDATION HIP SYSTEM INSTRUMENT
MDR report key: 178151
·
Received July 22, 1998
Report
- Report Number
- 1644408-1998-00002
- Event Type
- Other
- Date Received
- July 22, 1998
- Date of Event
- April 29, 1998
- Report Date
- July 20, 1998
- Manufacturer
- ENCORE ORTHOPEDICS, INC.
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EXTENDED SURGICAL TIME REQUIRED DUE TO BREAKAGE OF INSERTER INSTRUMENT IN IMPLANT. IMPLANT (HIP STEM) WAS REMOVED AND ANOTHER IMPLANT WAS SUCCESSFULLY IMPLANTED. (HIP STEM COVERED UNDER ANOTHER MDR.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION HIP SYSTEM INSTRUMENT | INSTRUMENT (MANUAL) | LXH | ENCORE ORTHOPEDICS, INC. | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |